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Huperzine A capsule and preparation method thereof

A technology for huperzine A and capsules, which is applied in the field of huperzine A capsules and its preparation, and can solve problems such as difficult quality assurance

Inactive Publication Date: 2009-06-24
YAOPHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It is difficult to ensure the quality of the preparation process by conventional methods, and it is also easy to degrade during storage

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] prescription:

[0027] Huperzine A 0.1g

[0028] Mannitol 259.9g

[0029] 1.5% (W / V) citric acid solution appropriate amount

[0030] 0.5M sodium hydroxide solution appropriate amount

[0031] Mannitol (filler) appropriate amount

[0032] Preparation process: ① take 0.1g huperzine A raw material, dissolve it with 1.5% (W / V) citric acid solution, and set aside; ② take 260g mannitol and dissolve it in 1500L purified water or water for injection, set aside; ③ mix the two solution, and then use 0.5M sodium hydroxide solution to adjust the pH value of the mixed solution to 3.9, and fill it in a shallow dish; ④ Freeze-drying (pre-freezing, the temperature drops to -40°C, freeze for two hours, vacuumize, and then freeze at a rate of 1 minute Raise the temperature to 10°C at a heating rate of 0.2°C, keep the temperature for 5 hours, then raise the temperature to 30°C at a heating rate of 0.4°C per minute, and leave the box after 4 hours at a constant temperature); The cont...

Embodiment 2

[0034] prescription:

[0035] Huperzine A 13g

[0036] Sorbitol 247g

[0037] 5% (W / V) citric acid solution appropriate amount

[0038] 0.5M sodium hydroxide solution appropriate amount

[0039] Sorbitol (filler) appropriate amount

[0040] Process: ① Take 0.1g Huperzine A raw material, dissolve it with 5% (W / V) citric acid solution, and set aside; ② Take 260g sorbitol and dissolve it in 1500L purified water or water for injection, set aside; ③ Mix the two solutions , and then use 0.5M sodium hydroxide solution to adjust the pH value of the mixture to 4.0, and fill it in a shallow plate; ④ Freeze-drying (pre-freezing, the temperature drops to -40°C, freeze for two hours, vacuumize, and then 0.2 per minute ℃ heating rate to raise the temperature to 10 ℃, constant temperature for 5 hours, then raise the temperature to 30 ℃ with a heating rate of 0.4 ℃ per minute, keep the temperature for 4 hours and leave the box); ⑤ out of the box and pulverize; Alkaline A content, calcula...

Embodiment 3

[0042] prescription:

[0043] Huperzine A 5g

[0044] Xylitol 260g

[0045] 3% (W / V) citric acid solution appropriate amount

[0046] 0.5M sodium hydroxide solution appropriate amount

[0047] Mannitol, xylitol (filler) appropriate amount

[0048] Process: ①Take 0.1g huperzine A raw material, dissolve it with 3% citric acid solution, and set aside; ②Take 260g xylitol and dissolve it in 1500L purified water or water for injection, set aside; ③Mix the two solutions, and then use 0.5 M sodium hydroxide solution adjusts the pH value of the mixed solution to 4.0, and fills it in a shallow dish; ④ freeze-drying (pre-freezing, the temperature drops to -40°C, freezes for two hours, vacuumizes, and then heats up at a rate of 0.2°C per minute Raise the temperature to 10°C, keep the temperature constant for 5 hours, then raise the temperature to 30°C at a rate of 0.4°C per minute, and leave the box after 4 hours at a constant temperature); ⑤ go out of the box and pulverize; ⑥ measure...

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Abstract

The invention discloses a novel huperzine A capsule ad a preparation method thereof. The huperzine A capsule consists of a huperzine A freeze-dried dispersion and a filling agent, and the freeze-dried dispersion of the huperzine A capsule is prepared through the freeze-drying process. Huperzine A is unstable to light and moist heat and has the incompatibility with most of auxiliary materials, and the preparation of the huperzine A capsule by the prior method is difficult to guarantee the quality and is also easy to degrade during the storage. The method overcomes the disadvantages, has simple process, and is suitable for production and application.

Description

technical field [0001] The invention relates to a huperzine A capsule and a preparation method thereof. Background technique [0002] Huperzine A (Huperzine A) chemical name: (5R,9R,11E)-5-amino-11-ethylene-5,6,9,10-tetrahydro-7-methyl-5,9-ethylene Acetyloctano-2(1H)-pyridone, an alkaloid extracted from the herbal medicine Melaleuca, is a cholinesterase inhibitor, has a selective inhibitory effect on true cholinesterase, and is easy to pass through the blood The brain barrier has the function of promoting memory reproduction and enhancing memory retention. It has been applied to benign memory disorders, improving patients' directed memory, associative learning, image recall, meaningless graphic recognition and portrait recall. [0003] Huperzine A is unstable to light and heat and humidity in practical applications, and has incompatibility with most excipients. It is difficult to ensure the quality of the preparation process by conventional methods, and it is also easy to ...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K31/439A61P25/28
Inventor 郭耀顺
Owner YAOPHARMA CO LTD
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